Pharmaceutical Investigator
The International Society for Pharmaceutical Engineering, Inc., Andover, MA, United States
We are seeking a Quality Assurance professional to support an established QA Investigations team. This role will act as the quality authority for deviation and investigation review, ensuring investigations are thorough, compliant, and aligned with GMP expectations. The ideal candidate brings hands on experience in either biotech manufacturing or Quality Control, followed by experience reviewing investigations from a QA perspective. Candidates without manufacturing or QC experience must demonstrate extended experience functioning as a quality authority reviewing investigations.
Key Responsibilities
Review and approve deviation investigations, root cause analyses, and corrective and preventive actions
Act as the quality authority to ensure investigations meet GMP and regulatory requirements
Assess investigation quality, completeness, and scientific rationale
Partner with Manufacturing, Quality Control, and other cross functional teams to drive timely investigation closure
Provide guidance and feedback to investigation owners to improve investigation effectiveness and compliance
Identify trends and recurring issues to support continuous improvement initiatives
Support audits, inspections, and internal reviews related to investigations
Required Qualifications
Bachelor’s degree in a scientific or technical discipline
Several years of experience in biotech manufacturing or Quality Control, followed by experience reviewing investigations in a QA role
OR extended experience serving as a quality authority reviewing investigations without prior manufacturing or QC background
Strong understanding of GMP principles and regulated manufacturing environments
Demonstrated experience reviewing and approving deviations and investigation documentation
Ability to apply quality judgment and clearly articulate findings and decisions
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Key Responsibilities
Review and approve deviation investigations, root cause analyses, and corrective and preventive actions
Act as the quality authority to ensure investigations meet GMP and regulatory requirements
Assess investigation quality, completeness, and scientific rationale
Partner with Manufacturing, Quality Control, and other cross functional teams to drive timely investigation closure
Provide guidance and feedback to investigation owners to improve investigation effectiveness and compliance
Identify trends and recurring issues to support continuous improvement initiatives
Support audits, inspections, and internal reviews related to investigations
Required Qualifications
Bachelor’s degree in a scientific or technical discipline
Several years of experience in biotech manufacturing or Quality Control, followed by experience reviewing investigations in a QA role
OR extended experience serving as a quality authority reviewing investigations without prior manufacturing or QC background
Strong understanding of GMP principles and regulated manufacturing environments
Demonstrated experience reviewing and approving deviations and investigation documentation
Ability to apply quality judgment and clearly articulate findings and decisions
#J-18808-Ljbffr